A Multicenter, Randomized Controlled Trial of Angiotensin-Neprilysin Inhibition (ARNI) in the Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Cardiovascular events
研究概览
简要总结
This study is a randomized controlled multicenter clinical trial, in which about 340 patients with newly diagnosed or prior diagnosed chronic heart will be recruited. Patients will be randomly divided into Angiotensin-Neprilysin Inhibition (ARNI) group and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEI/ARB) group. All-cause death, cardiac death and re-hospitalization due to heart failure will be evaluated in 1, 3, 6, 12 months after recruitment.
详细描述
Chronic heart failure is associated with poor prognosis in cardiac patients, although systemic effective drugs has been applied in these patients. European Society of Cardiology (ESC) has recommended ARNI Sacubitril/Valsartan as first-line drugs in replacement of ACEI (I, B) in 2016 for these patients. While American College of Cardiology and The American Heart Association (ACC/AHA) made a first-line recommendation that patients with heart failure due to reduced ejection fraction (HFrEF) could be administrated ARNI directly. Hence, we apply this trial to find if ARNI could replace ACEI/ARB to provide insights for better treatment of chronic heart failure in China. This study is a randomized controlled multicenter clinical trial, in which about 340 patients with newly diagnosed or prior diagnosed chronic heart will be recruited. Patients will be randomly divided into Angiotensin-Neprilysin Inhibition (ARNI) group and ACEI/ARB group. All-cause death, cardiac death and re-hospitalization due to heart failure will be evaluated in 1, 3, 6, 12 months after recruitment. Other safety assessment including left ventricular ejection fraction (LVEF), 6 minutes walk test will be followed up as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HFrEF, defined as LVEF≤40% and New York Heart Association (NYHA) class ≥ II.
- •Plasma NT-proBNP ≥ 600 pg/ml, or NT-proBNP ≥ 400 pg/ml if patients have been hospitalized for heart failure in 12 months.
- •If patients have been taking ACEI/ARB at recruitment, a stable dose equivalent to at least 10mg/day of enalapril will be required.
- •Volunteer for the study and sign the informed consent.
排除标准
- •Symptomatic hypotension, systolic blood pressure < 95 mmHg at baseline.
- •eGFR < 30 ml(/min*1.73m2) at baseline.
- •Serum potassium > 5.4 mmol/L at baseline.
- •Contraindication of ACEI or ARB.
研究组 & 干预措施
Newly diagnosed HFrEF ARNI
Newly diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study.
干预措施: Entresto (Drug)
Newly diagnosed HFrEF ACEI/ARB
Newly diagnosed HFrEF patients will be administered ACEI/ARB according to the clinical condition among the whole study.
干预措施: ACEI/ARB (Drug)
Prior diagnosed HFrEF ARNI
Prior diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study.
干预措施: Entresto (Drug)
Prior diagnosed HFrEF ACEI/ARB
Prior diagnosed HFrEF patients will be administered ACEI/ARB according to the clinical condition among the whole study.
干预措施: ACEI/ARB (Drug)
结局指标
主要结局
Cardiovascular events
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Composite outcomes of all-cause death including cardiac death and re-hospitalization due to heart failure
次要结局
- Six-minutes walking test(Test in 1, 3, 6, 12 months comparing to the baseline.)
- LVEF(Test in 1, 3, 6, 12 months comparing to the baseline.)